Description
The landscape of cancer diagnostics is evolving with molecular and protein biomarkers indispensable for accurate diagnosis, therapy selection, monitoring treatment response, and early detection of cancer recurrence. Kalorama Information’s The World Market for Cancer Diagnostics, 2024-2029 delivers an authoritative and comprehensive analysis of the global cancer in vitro diagnostics (IVD) market, including industry-defining trends, market sizing, and growth opportunities.
This report offers an in-depth review of the cancer IVD market, including expert insights into significant segment markets:
- Oncology molecular assays (including companion diagnostics)
- Molecular screening for colorectal cancer
- Immunohistochemistry (IHC)
- Tumor marker immunoassays
- In situ hybridization (ISH/FISH)
- Human papillomavirus (HPV) tests
- Circulating tumor cell (CTC) assays
While focusing on these pivotal categories, the report provides limited coverage of imaging, hematology, clinical chemistry, flow cytometry, Pap smears, and traditional stains. Key developments, product launches, and regulatory announcements that shape the cancer IVD market are analyzed, along with forecasts for market growth from 2024 to 2029.
Key Highlights
- Shift to Biofluid-Based Diagnostics: Although tissue-based diagnostics dominate the current market, there is growing momentum toward biofluid-based tests (e.g., blood, urine) for cancer detection and monitoring.
- Market Dynamics: The forecasted growth reflects anticipated product innovations, cancer epidemiology trends, and demographic shifts, with revenue estimates based on factory-level sales to end users.
- Comprehensive Insights: The report incorporates global cancer statistics, technological advancements, and competitive trends to provide a nuanced view of the market’s evolution.
Report Structure
- Executive Summary – A concise overview of key findings and market scope.
- Introduction and Overview – Background and terminology for context.
- Market Trends – Emerging trends shaping the cancer diagnostics industry.
- Market Revenues and Forecasts – Detailed revenue projections by segment through 2029.
- Competitive Analysis – Analysis of key market players and competitive developments.
- Corporate Profiles – Profiles of leading companies in the cancer diagnostics space.
Methodology
The report leverages a robust combination of primary and secondary research. Sources include company reports, government documents, research journals, and industry databases. In-depth interviews with key stakeholders, such as company representatives, researchers, and clinicians, further validate the market forecasts and uncover emerging opportunities.
Major data sources include the American Cancer Society, FDA, World Health Organization, Cancer Research UK, and the European Diagnostic Manufacturers Association, among others. Kalorama Information’s proprietary databases and previous market reports also provide foundational insights.
Table of Contents
Chapter 1: Executive Summary
Overview
Scope and Methodology
Market Overview and Analysis
- Figure 1-1: Global Cancer IVD Market Size and Forecast, 2024-2029 ($ million)
Chapter 2: Introduction, Background, and Overview
Global Cancer Burden
- Figure 2-1: Incidence of Cancer, by Type, 2020 (Bladder, Breast, Cervix Uteri, Colorectum, Liver, Lung, Oesophagus, Prostate, Stomach, Thyroid)
- Figure 2-2: Global Distribution of Cancer Incidence, Estimated Number of New Cases, by Type, 2020 (%) (Breast, Cervix Uteri, Colorectum, Liver, Lung, Prostate, Stomach, Thyroid, Other Cancers)
Introduction to Cancer
Biochemistry of Cancer Cells
Causes of Cancer Growth May Shed Light on Treatment
Environmental Factors, DNA, RNA
- Table 2-1: Virus Association with Human Cancer
Cellular Oncogenes
Tumor Suppressor Genes
Large Range of IVDs Applied
Histology and Cytology
In Situ Hybridization (ISH)
Immunoassays
Polymerase Chain Reaction (PCR)
Companion Diagnostics
- Table 2-2: FDA Approved or Cleared Companion Diagnostic (CDx) Tests and Corresponding Therapies, Oncology
- Table 2-3: Selected Major Biomarkers in Oncology Personalized Medicine Tests
Predictive Biomarker Tests for Drug-Gene Match
DNA and RNA Variants
- Table 2-4: Human Genome and Cancer Gene Identification
- Table 2-5: Relevant DNA/RNA Variants for Top Six Cancer Types (Breast, Colon, Gastric, Liver/Biliary, Lung, Prostate)
- Table 2-6: Relevant DNA/RNA Variants for Top Six Cancer Types (excl. top six) (Brain, Cervical, Esophagus, Leukemia, Lymphoma, Melanoma, Ovarian, Pancreatic, Sarcoma, Thyroid)
Diagnostics in Hereditary Cancer Diagnosis
- Table 2-7: Select Innovations in Molecular Cancer Risk Detection and Prevention
- Table 2-8: Selected Companies Offering LDTs for Hereditary Risk of Cancer
Cancer Markers in Widespread Usage
Cancer Treatment Approaches
- Table 2-9: Characteristics of Cancer Treatment Approaches (Chemotherapy, Hormone Therapy, Precision Therapy)
What is Precision Cancer Therapy?
- Table 2-10: Industry Recognized Terms for Companion Diagnostics and Personalized Medicine
Chapter 3: Market Trends
Growth in Precision Medicine, Companion Diagnostics, Related Applications
- Table 3-1: Selected Molecular Companion and Complementary Assays for Cancer
- Table 3-2: Selected Pharmacogenomic Biomarkers and Drugs’ Labeling, FDA
- Table 3-3: Selected FDA Cleared/Approved Companion Diagnostic Tests and Therapeutic Application
Pharmacodiagnostic Tests
- Table 3-4: Selected Liquid Biopsy Innovations
Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
Circulating Tumor Cell (CTC) Tests
Sample Collection Products
Exosome Sequencing
Next-Generation Sequencing Tests
Whole-Genome Sequencing
Exome Sequencing
RNA Sequencing
Regulatory Influences
Companies
Advanced Analysis Solutions
- Table 3-5: Selected Advanced Histology Techniques
Automation of Histology
- Table 3-6: Selected Histology Lab Automation Technologies
- Table 3-7: Histology Information Technology Tools
Artificial Intelligence
Mass Spectrometry
- Table 3-8: Selected Mass Spectrometry-Based Oncology Tests
Regulatory and Reimbursement Trends
Reimbursement Breakthroughs and Challenges
Next Generation Sequencing Coverage
Companion Diagnostics Seeing Development in Regulations
- Table 3-9: FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations and the Associated Therapeutic Products
- Figure 3-1: Growth in Precision Cancer Therapeutics by Company 2010 vs. 2022 ($ million)
- Figure 3-2: Growth Trend by Company, 2010-2022 CAGR: Precision Cancer Therapeutics (%)
Laboratory Developed Tests (LDTs)
Food and Drug Administration
Directive 98/79/EC
Health Canada Changes and Forecasted Action
International Growth Opportunities
Chapter 4: Market Revenues and Forecast
Market Revenue 2024-2029
- Table 4-1: Cancer IVD Market Revenues, by Segment, 2024-2029 ($ million) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay – IHC; Immunoassay – Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
- Figure 4-1: Cancer IVD Market Revenues, by Segment, 2024-2029 ($ million) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay – IHC; Immunoassay – Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
- Figure 4-2: Cancer IVD Market Revenue, CAGR by Segment, 2024-2029 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay – IHC; Immunoassay – Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
- Table 4-2: Cancer IVD Market Revenues, Share by Segment, 2024 vs. 2029 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay – IHC; Immunoassay – Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
- Figure 4-3: Cancer IVD Market Revenues, Share by Segment, 2024 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay – IHC; Immunoassay – Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
Molecular Cancer Test Regional Distribution
- Table 4-3: Global Molecular Cancer Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
- Figure 4-4: Global Molecular Cancer Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
Histology and Cytology
- Table 4-4: Global Histology/Cytology Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
- Figure 4-5: Global Histology/Cytology Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
Molecular Cancer Diagnostics Segment by Technology/Method
- Table 4-5: Techniques Used in Molecular Cancer Diagnostics, 2024 & 2029 (%) (Arrays, ISH, NGS, PCR, Others)
- Figure 4-6: Techniques Used in Molecular Cancer Diagnostics, 2024 & 2029 (%) (Arrays, ISH, NGS, PCR, Others)
HPV Market and Regional Distribution
- Table 4-6: Selected HPV Test Innovations
- Table 4-7: Global HPV Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
- Figure 4-7: Global HPV Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
Drivers and Challenges
Clinical Utility of Molecular Diagnostics
Technological Advancements Including NGS Adopted Incrementally
Chapter 5: Competitive Analysis
Recent Regulatory Approvals
- Table 5-1: Recent Regulatory Approvals in Cancer IVD, May 2022 – December 2024
Immunoassay Competitive Trends
IHC Market
Competition in ISH
Molecular Cancer Diagnostics Landscape
HPV
Liquid Biopsy and CTCs
Deals and Collaborations
- Table 5-2: Recent Deals and Collaborations in Cancer IVD, January 2022 – December 2024
- Table 5-3: CDx Relevant Partnerships and Collaborations
- Table 5-4: Product/ Technology Introductions in Cancer IVD, January 2022 – November 2024
Chapter 6: Corporate Profiles
Abbott Diagnostics
Company Overview
- Companion Testing
- Liquid Biopsy
Agendia BV
Company Overview
Agilent Technologies
Company Overview
- Agilent in Genomics
- Cytogenetic Analysis
- Sequencing
- CRISPR
- Flow Cytometry
- Companion Diagnostics
Asuragen (Bio-Techne)
Company Overview
Beckman Coulter (Danaher)
Company Overview
Becton, Dickinson and Company (BD)
Company Overview
- Cytology and HPV
- Flow Cytometry
- Licensing
Bio-Rad Laboratories
Company Overview
- Immunoassays
- Liquid Biopsy
- Droplet Digital PCR
Biocartis
Company Overview
Biodesix
Company Overview
Biotheranostics, Inc. (Hologic)
Company Overview
Danaher Corp.
Company Overview
Exact Sciences
Company Overview
Exosome Diagnostics (Bio-Techne)
Company Overview
Hologic
Company Overview
Illumina
Company Overview
Leica Biosystems (Danaher)
Company Overview
- Digital Pathology
- Stain Reagents
- Lab Systems
- Sample Handling
- Circulating Tumor Cells (CTCs)
- Artificial Intelligence
Menarini-Silicon Biosystems
Company Overview
Qiagen
Company Overview
- Precision Medicine / Companion Diagnostics
- Sample Prep, Informatics
- Digital PCR
- Bioinformatics
- Liquid Biopsy
Roche
Company Overview
- HPV
- Cancer Companion Testing
- Liquid Biopsy
- IT in Anatomical Pathology
- Information Technology
- Roche Tissue Diagnostics / Ventana
- Immunohistochemistry – IHC
- Cervical Cancer Screening
- Companion Diagnostics
Sysmex Inostics
Company Overview
- Hematology
- Coagulation
- Urinalysis
- Immunoassays
- Lab Information System
- Information Technology
- Flow Cytometry
- Precision Medicine / Companion Test Diagnostics
- Liquid Biopsy
- Exosomes
- Oncology
Thermo Fisher Scientific
Company Overview
- Next Generation Sequencing
- Liquid Biopsy
- Oncology Companion Diagnostics
